| Primary Device ID | B922F01500060 |
| NIH Device Record Key | 0bef3358-5761-4242-8913-d7c9c0956b7d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Paddle Distractor |
| Version Model Number | F015.0006 |
| Catalog Number | F015.0006 |
| Company DUNS | 860396609 |
| Company Name | INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B922F01500060 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B922F01500060]
Moist Heat or Steam Sterilization
[B922F01500060]
Moist Heat or Steam Sterilization
[B922F01500060]
Moist Heat or Steam Sterilization
[B922F01500060]
Moist Heat or Steam Sterilization
[B922F01500060]
Moist Heat or Steam Sterilization
[B922F01500060]
Moist Heat or Steam Sterilization
[B922F01500060]
Moist Heat or Steam Sterilization
[B922F01500060]
Moist Heat or Steam Sterilization
[B922F01500060]
Moist Heat or Steam Sterilization
[B922F01500060]
Moist Heat or Steam Sterilization
[B922F01500060]
Moist Heat or Steam Sterilization
[B922F01500060]
Moist Heat or Steam Sterilization
[B922F01500060]
Moist Heat or Steam Sterilization
[B922F01500060]
Moist Heat or Steam Sterilization
[B922F01500060]
Moist Heat or Steam Sterilization
[B922F01500060]
Moist Heat or Steam Sterilization
[B922F01500060]
Moist Heat or Steam Sterilization
[B922F01500060]
Moist Heat or Steam Sterilization
[B922F01500060]
Moist Heat or Steam Sterilization
[B922F01500060]
Moist Heat or Steam Sterilization
[B922F01500060]
Moist Heat or Steam Sterilization
[B922F01500060]
Moist Heat or Steam Sterilization
[B922F01500060]
Moist Heat or Steam Sterilization
[B922F01500060]
Moist Heat or Steam Sterilization
[B922F01500060]
Moist Heat or Steam Sterilization
[B922F01500060]
Moist Heat or Steam Sterilization
[B922F01500060]
Moist Heat or Steam Sterilization
[B922F01500060]
Moist Heat or Steam Sterilization
[B922F01500060]
Moist Heat or Steam Sterilization
[B922F01500060]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-17 |
| Device Publish Date | 2023-08-09 |
| B922F008000103 - Cervical Awl | 2024-10-25 Cervical Awl |
| B922A00471300 - ACURA Stabilization System Ø 4.5 x 30 mm Polyaxial Screw - NT | 2024-04-10 ACURA Stabilization System Ø 4.5 x 30 mm Polyaxial Screw - NT |
| B922F00400780 - Screw Head Positioner | 2024-04-09 Screw Head Positioner |
| B922F00403270 - ACURA Stabilization System - Rigid Screw Driver,SNAP ON (NT) | 2024-04-05 Rigid Screw Driver, SNAP ON (NT) |
| B922A00471350 - ACURA Stabilization System Ø 4.5 x 35 mm Polyaxial Screw - NT | 2024-03-26 ACURA Stabilization System Ø 4.5 x 35 mm Polyaxial Screw - NT |
| B922A00471400 - ACURA Stabilization System Ø 4.5 x 40 mm Polyaxial Screw - NT | 2024-03-26 ACURA Stabilization System Ø 4.5 x 40 mm Polyaxial Screw - NT |
| B922A00471450 - ACURA Stabilization System Ø 4.5 x 45 mm Polyaxial Screw - NT | 2024-03-26 ACURA Stabilization System Ø 4.5 x 45 mm Polyaxial Screw - NT |
| B922F00300210 - Alignment Jig | 2023-11-09 Alignment Jig |